Appropriate Use of Nevirapinefor Long‐Term Therapy

Open Access
Publisher Website
Google Scholar
Abstract
To the Editor—The recent article by Sanne et al. [1] described possible risk factors associated with hepatic adverse events that can occur while nevirapine is being taken in a clinical trial. We are concerned about several key issues either overlooked or minimized in the article. It is important to understand that the preliminary results of the FTC-302 study provided the impetus for Boehringer Ingelheim (BI) to conduct a comprehensive analysis of hepatotoxicity in all large BI controlled and uncontrolled studies. This analysis resulted in warnings that female sex and higher CD4 cell count at the initiation of therapy increases the risk of hepatotoxicity, particularly during the first 6 weeks of treatment. This information has been widely communicated through changes to the prescribing information and through BI communications to physicians. Most recently, BI has recommended against the initiation of nevirapine treatment in women with CD4 cell counts >250 cells/mm3 or in men with CD4 cell counts >400 cells/mm3 unless the benefit outweighs the risk (see http://www.fda.gov/cder/drug/advisory/Nevirapine.htm). As shown in figure 1, there is a clear demarcation in the risk of developing nevirapine-associated symptomatic hepatitis at the CD4 cell count cutoffs mentioned above

This publication has 0 references indexed in Scilit: